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Open-Label, Long-Term Treatment Study, to Assess the Long-Term Safety and Tolerability and Efficacy of Neramexane in Patients With Subjective Tinnitus (OLLTT)

Primary Purpose

Subjective Tinnitus

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Neramexane mesylate
Sponsored by
Merz Pharmaceuticals GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Subjective Tinnitus

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Main Inclusion Criteria:

  • Male or female patients who have successfully completed one of the double-blind Phase 3 tinnitus studies of Merz with Neramexane mesylate
  • patients aged equal or older 18 but not older than 75 years with clinical diagnosis of first onset, persistent (i.e. tinnitus should never be absent for more than 24 hours in a row), subjective, uni-or bilateral subacute tinnitus at the timepoint of the lead-in study

Main Exclusion Criteria:

  • clinical diagnosis of intermittent or pulsatile tinnitus
  • Patients who have tinnitus as a concomitant symptom of an otological/neurological disease (such as otitis media, Meniére´s disease, otosclerosis etc.)

Sites / Locations

  • Paradigm Clinical Research
  • Providence Clinical Research
  • Central California Clinical Research
  • UC Davis Health System Department of Otolaryngology
  • Colorado Otolaryngology Associates
  • New West Physicians
  • Visions Clinical Research
  • Clinical Research of West Florida
  • Deerpath Physicians Group
  • Knight Center for Integrated Health,
  • University of Kansas Department of Otolaryngology Head & Neck Surgery
  • Heartland Research Associates, LLC.
  • Heartland Research Associates, LLC.
  • Commonwealth Ear, Nose & Throat
  • Glacier Ear, Nose, and Throat, Head and Neck Surgery, P.C.
  • Immedicenter
  • David L. Bortniker, M.D, FACS
  • Montefiore Medical Center Attn: Anxiety and Depression Center
  • Erie County Medical Center, Department of Rehabilitation Medicine
  • Cary Medical Research
  • Wake Research Associates, LLC
  • Wilmington Medical Research
  • Piedmont Medical Research
  • Medical University of South Carolina - Department of Otolaryngology, Department of Otolaryngology - Head & Neck Surgery
  • Future Search Trials of Neurology
  • FutureSearch Trials of Dallas
  • R/D Clinical Research, Inc.
  • South Texas Research Alliance LLC
  • Research Across America
  • Advanced Clinical Research
  • Health Research of Hampton Roads, Inc.
  • Krankenhaus der Elisabethinen
  • Bezirkskrankenhaus Kufstein Dr. Christof Pauli (PI: Prim. Dr. Peter Ostertag
  • Clin Pharm International GmbH, Zentrum Wien
  • University Hospital Brussels
  • Clinique Universitaire Saint-luc
  • AZ Sint Lucas, ENT department
  • University Hospital Leuven, ENT Department
  • Consultório Dr. Marcelo Rates
  • Osmar Clayton Person
  • Instituto Ganz Sanchez
  • Clínica OTOSUL
  • Medico
  • prof. MUDr. Ivo Šlapák
  • Teaching University Hospital, ORL klinika
  • ORL oddělení, Karlovarská krajská nemocncie a.s.
  • Oblastní nemocnice Kladno a.s., Nemocnice Středočeského kraje
  • Pro-audio,s.r.o.-private ENT clinic
  • ORL oddělení, Všeobecná Fakultní Nemocnice v Praze
  • ORL oddělení , Karlovarská krajská nemocnice a. s.
  • Dr. Ebbo
  • Dr. Sarfati
  • Centre Hospitalier de Bretagne Sud Service ORL-B9
  • Dr. Bonfils
  • Dr. Ohresser
  • Hopital Nord
  • Dr. Fraysse
  • Service ORL CHU Bretonneau
  • Hopital Paul BROUSSE Polyclinique
  • Dr. Kühne, Elisabeth
  • Dr. med. Norbert Pasch
  • Charité, Universitätsmedizin Berlin-Tinnituszentrum
  • Klin. Forschung Berlin Buch GmbH
  • Dr. med. Frank Reintjes
  • DM Helena Sigal
  • Dr. Klaus Peter Jayme
  • Dr. Christian Dörr
  • HNO-Praxis im Gesundheitszentrum
  • Dr. Gieselmann, Werner
  • Dr. Wolfgang Lotte
  • Dr. Dr. med. Hans-Detlev Stahl
  • HNO Praxis
  • Dr. Dannesberger
  • ClinPharm International
  • HNO Gemeinschaftpraxis
  • Martin Canis, MD
  • Dr. Susanne Wiedemann
  • Dr. med. Ulrike Walter
  • Dr. Norbert Staab
  • Dr. Hannelore Neumaier
  • Unidad Médica de Especialidades del Noroeste (UMEN)
  • Hospital General de Chihuahua. "Dr. Salvador Anchondo"
  • Hospital Christus Muguerza del Parque
  • Internal Medicine Clin Trials (IMED)
  • Hospital Civil de Guadalajara
  • Grupo Médico Terranova
  • Clinical Research Instutute S.C.
  • Instituto Biomédico de Investigación A.C.
  • Unidad de Investigación Clínica Cardiometábolica de Occidente S.C. (UNICAMO)
  • Monterrey International Research Center (MIRC)
  • Hospital Universitario Dr. José Eleuterio González. Edificio Elizondo Barragán, Servicio de Otorrinolaringología
  • Hospital Central "Dr. Ignacio Morones Prieto" Servicio de Otorrinolaringología
  • Andromed Zoetermeer
  • Andromed Oost
  • Rijnland Ziekenhuis, ENT department
  • Andromed Rotterdam
  • Adromed Nijmegen
  • Andromed Leiden
  • Andromed Breda
  • Uniwersytecki Szpital Kliniczny w Bialymstoku
  • Niepubliczny Zaklad Opieki Zdrowotnej Prywatne Centrum Medyczne PROMEDIS
  • Szpital Miejski im. J.Brudzinskiego
  • Samodzielny Publiczny Szpital Kliniczny im. Andrzeja Mieleckiego Slaskiego Uniwersytetu Medycznego w Katowicach
  • NZOZ Specjalistyczne Centrum Medyczne Nowomed
  • Niepubliczny Zaklad Opieki Zdrowotnej PROMED
  • Specjalistyczny Gabinet Otolaryngologiczny
  • Szpital Specjalistyczny im. Stefana Zeromskiego, SP ZOZ w Krakowie, Oddzial Otolaryngologii
  • Samodzielny Publiczny Zaklad Opieki Zdrowotnej, Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Lodzi
  • Wojewodzki Szpital Specjalistyczny im. Stefana Kardynała Wyszynskiego Samodzielny Publiczny Zaklad Opieki Zdrowotnej
  • Wojewodzki Szpital Specjalistyczny w Olsztynie
  • Instytut Fizjologii i Patologii Sluchu
  • Samodzielny Publiczny Szpital Kliniczny nr 1 we Wroclawiu
  • Hospital Militar Regional nº 1 Serviço de Otorrinolaringologia
  • Louis Leipoldt Mediclinic
  • Lakeview Hospital
  • 1007 Louis Pasteur Building
  • GCT Eastmed Clinical Trial centre
  • Constantiaberg Medi Clinic,
  • Prince Alfred House
  • Hospital Sagunto
  • Fundación Hospital de Alcorcón, Otorhinolaryngology
  • Hospital Clínico Barcelona, Dept. Of ORL
  • Hospital Puerta del Hierro, Madrid- Servicio de ORL
  • Hospital Universitario Príncipe de Asturias
  • Clínica Universitaria de Navarra, Dept. ORL
  • Hospital Universitario de Salamanca- Hospital Virgen de la Vega
  • Oldfield Surgery
  • Addenbrooke's Hospital
  • Avondale Surgery, Research Office
  • Burbage Surgery
  • The university Hospitals of Leicester, Leicester Royal Infirmary
  • The Freeman Hospital
  • Wansford and Kings Cliffe Practice
  • Frome Medical Practice
  • Sherbourne Medical Centre

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1, verum

Arm Description

Outcomes

Primary Outcome Measures

Descriptive analyses of TBF-12 (Tinnitus-Beeinträchtigungs-Fragebogen 12 "Tinnitus Handicap Inventory 12")total score and its subscores, of the Tinnitus Rating Scale and its single items as well as of SF-36 and safety/tolerability parameters

Secondary Outcome Measures

Full Information

First Posted
January 21, 2009
Last Updated
November 27, 2012
Sponsor
Merz Pharmaceuticals GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT00827008
Brief Title
Open-Label, Long-Term Treatment Study, to Assess the Long-Term Safety and Tolerability and Efficacy of Neramexane in Patients With Subjective Tinnitus
Acronym
OLLTT
Official Title
An Open-Label, Long-Term Treatment Study to Assess the Long-Term Safety and Tolerability and Efficacy of Neramexane With Subjective Tinnitus
Study Type
Interventional

2. Study Status

Record Verification Date
November 2012
Overall Recruitment Status
Terminated
Study Start Date
January 2009 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merz Pharmaceuticals GmbH

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to investigate the long-term safety and tolerability and efficacy of neramexane mesylate in the long-term treatment of subjective tinnitus after a completed double-blind randomized placebo controlled study

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subjective Tinnitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
821 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1, verum
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Neramexane mesylate
Intervention Description
Up-titration treatment period of 5 weeks up to 75mg Neramexane mesylate oral per day followed by 49 weeks treatment maintenance
Primary Outcome Measure Information:
Title
Descriptive analyses of TBF-12 (Tinnitus-Beeinträchtigungs-Fragebogen 12 "Tinnitus Handicap Inventory 12")total score and its subscores, of the Tinnitus Rating Scale and its single items as well as of SF-36 and safety/tolerability parameters
Time Frame
54 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Main Inclusion Criteria: Male or female patients who have successfully completed one of the double-blind Phase 3 tinnitus studies of Merz with Neramexane mesylate patients aged equal or older 18 but not older than 75 years with clinical diagnosis of first onset, persistent (i.e. tinnitus should never be absent for more than 24 hours in a row), subjective, uni-or bilateral subacute tinnitus at the timepoint of the lead-in study Main Exclusion Criteria: clinical diagnosis of intermittent or pulsatile tinnitus Patients who have tinnitus as a concomitant symptom of an otological/neurological disease (such as otitis media, Meniére´s disease, otosclerosis etc.)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Expert
Organizational Affiliation
Merz Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Paradigm Clinical Research
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85705
Country
United States
Facility Name
Providence Clinical Research
City
Burbank
State/Province
California
ZIP/Postal Code
91505
Country
United States
Facility Name
Central California Clinical Research
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
UC Davis Health System Department of Otolaryngology
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Colorado Otolaryngology Associates
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80909
Country
United States
Facility Name
New West Physicians
City
Golden
State/Province
Colorado
ZIP/Postal Code
80401
Country
United States
Facility Name
Visions Clinical Research
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33472
Country
United States
Facility Name
Clinical Research of West Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33603
Country
United States
Facility Name
Deerpath Physicians Group
City
Gurnee
State/Province
Illinois
ZIP/Postal Code
60031
Country
United States
Facility Name
Knight Center for Integrated Health,
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61614
Country
United States
Facility Name
University of Kansas Department of Otolaryngology Head & Neck Surgery
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160-0001
Country
United States
Facility Name
Heartland Research Associates, LLC.
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67205
Country
United States
Facility Name
Heartland Research Associates, LLC.
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67207
Country
United States
Facility Name
Commonwealth Ear, Nose & Throat
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40207
Country
United States
Facility Name
Glacier Ear, Nose, and Throat, Head and Neck Surgery, P.C.
City
Kalispell
State/Province
Montana
ZIP/Postal Code
59901
Country
United States
Facility Name
Immedicenter
City
Bloomfield
State/Province
New Jersey
ZIP/Postal Code
07003
Country
United States
Facility Name
David L. Bortniker, M.D, FACS
City
Somerville
State/Province
New Jersey
ZIP/Postal Code
08876
Country
United States
Facility Name
Montefiore Medical Center Attn: Anxiety and Depression Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10867
Country
United States
Facility Name
Erie County Medical Center, Department of Rehabilitation Medicine
City
Buffalo
State/Province
New York
ZIP/Postal Code
14221
Country
United States
Facility Name
Cary Medical Research
City
Cary
State/Province
North Carolina
ZIP/Postal Code
27518
Country
United States
Facility Name
Wake Research Associates, LLC
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Wilmington Medical Research
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
Piedmont Medical Research
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Medical University of South Carolina - Department of Otolaryngology, Department of Otolaryngology - Head & Neck Surgery
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425-5500
Country
United States
Facility Name
Future Search Trials of Neurology
City
Austin
State/Province
Texas
ZIP/Postal Code
78756
Country
United States
Facility Name
FutureSearch Trials of Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
R/D Clinical Research, Inc.
City
Lake Jackson
State/Province
Texas
ZIP/Postal Code
77566
Country
United States
Facility Name
South Texas Research Alliance LLC
City
Laredo
State/Province
Texas
ZIP/Postal Code
78041
Country
United States
Facility Name
Research Across America
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
Advanced Clinical Research
City
West Jordon
State/Province
Utah
ZIP/Postal Code
84088
Country
United States
Facility Name
Health Research of Hampton Roads, Inc.
City
Newport News
State/Province
Virginia
ZIP/Postal Code
23606
Country
United States
Facility Name
Krankenhaus der Elisabethinen
City
Graz
ZIP/Postal Code
8020
Country
Austria
Facility Name
Bezirkskrankenhaus Kufstein Dr. Christof Pauli (PI: Prim. Dr. Peter Ostertag
City
Kufstein
ZIP/Postal Code
6330
Country
Austria
Facility Name
Clin Pharm International GmbH, Zentrum Wien
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Facility Name
University Hospital Brussels
City
Brussels
ZIP/Postal Code
1090
Country
Belgium
Facility Name
Clinique Universitaire Saint-luc
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Facility Name
AZ Sint Lucas, ENT department
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
University Hospital Leuven, ENT Department
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Consultório Dr. Marcelo Rates
City
Belo Horizonte/Mimaf Gerais
ZIP/Postal Code
CEP 30150-270
Country
Brazil
Facility Name
Osmar Clayton Person
City
Santo André/SP
ZIP/Postal Code
zip 09060-650
Country
Brazil
Facility Name
Instituto Ganz Sanchez
City
São Paulo/SP
ZIP/Postal Code
ZIP CODE: 05469-000
Country
Brazil
Facility Name
Clínica OTOSUL
City
Valenca/RJ
ZIP/Postal Code
CEP.: 27211-130
Country
Brazil
Facility Name
Medico
City
Chodov
State/Province
Prague
ZIP/Postal Code
4
Country
Czech Republic
Facility Name
prof. MUDr. Ivo Šlapák
City
Brno
ZIP/Postal Code
602 00
Country
Czech Republic
Facility Name
Teaching University Hospital, ORL klinika
City
Brno
ZIP/Postal Code
65691
Country
Czech Republic
Facility Name
ORL oddělení, Karlovarská krajská nemocncie a.s.
City
Karlovy Vary
ZIP/Postal Code
360 66
Country
Czech Republic
Facility Name
Oblastní nemocnice Kladno a.s., Nemocnice Středočeského kraje
City
Kladno
ZIP/Postal Code
272 59
Country
Czech Republic
Facility Name
Pro-audio,s.r.o.-private ENT clinic
City
Mladá Boleslav
ZIP/Postal Code
29301
Country
Czech Republic
Facility Name
ORL oddělení, Všeobecná Fakultní Nemocnice v Praze
City
Praha
ZIP/Postal Code
128 08
Country
Czech Republic
Facility Name
ORL oddělení , Karlovarská krajská nemocnice a. s.
City
Sokolov
ZIP/Postal Code
356 01
Country
Czech Republic
Facility Name
Dr. Ebbo
City
Issy les moulineaux
ZIP/Postal Code
92130
Country
France
Facility Name
Dr. Sarfati
City
La seyne sur Mer
ZIP/Postal Code
83500
Country
France
Facility Name
Centre Hospitalier de Bretagne Sud Service ORL-B9
City
Lorient
ZIP/Postal Code
2233-56322
Country
France
Facility Name
Dr. Bonfils
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
Dr. Ohresser
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
Hopital Nord
City
Saint-etienne
ZIP/Postal Code
42055
Country
France
Facility Name
Dr. Fraysse
City
Toulouse cedex
ZIP/Postal Code
31059
Country
France
Facility Name
Service ORL CHU Bretonneau
City
Tours
ZIP/Postal Code
37044
Country
France
Facility Name
Hopital Paul BROUSSE Polyclinique
City
Villejuif
ZIP/Postal Code
94800
Country
France
Facility Name
Dr. Kühne, Elisabeth
City
Halle
State/Province
Saale
ZIP/Postal Code
06112
Country
Germany
Facility Name
Dr. med. Norbert Pasch
City
Aachen
ZIP/Postal Code
52074
Country
Germany
Facility Name
Charité, Universitätsmedizin Berlin-Tinnituszentrum
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Klin. Forschung Berlin Buch GmbH
City
Berlin
ZIP/Postal Code
13125
Country
Germany
Facility Name
Dr. med. Frank Reintjes
City
Braunschweig
ZIP/Postal Code
38100
Country
Germany
Facility Name
DM Helena Sigal
City
Chemnitz
ZIP/Postal Code
09120
Country
Germany
Facility Name
Dr. Klaus Peter Jayme
City
Darmstadt
ZIP/Postal Code
64283
Country
Germany
Facility Name
Dr. Christian Dörr
City
Dresden
ZIP/Postal Code
01277
Country
Germany
Facility Name
HNO-Praxis im Gesundheitszentrum
City
Duisburg
ZIP/Postal Code
47179
Country
Germany
Facility Name
Dr. Gieselmann, Werner
City
Heiligenhaus
ZIP/Postal Code
42579
Country
Germany
Facility Name
Dr. Wolfgang Lotte
City
Iserlohn
ZIP/Postal Code
58642
Country
Germany
Facility Name
Dr. Dr. med. Hans-Detlev Stahl
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
HNO Praxis
City
Lichtenfels
ZIP/Postal Code
96215
Country
Germany
Facility Name
Dr. Dannesberger
City
Lorsch
ZIP/Postal Code
64653
Country
Germany
Facility Name
ClinPharm International
City
Magdeburg
ZIP/Postal Code
39104
Country
Germany
Facility Name
HNO Gemeinschaftpraxis
City
Meppen
ZIP/Postal Code
48716
Country
Germany
Facility Name
Martin Canis, MD
City
Munich
ZIP/Postal Code
81377
Country
Germany
Facility Name
Dr. Susanne Wiedemann
City
Nuernberg
ZIP/Postal Code
90443
Country
Germany
Facility Name
Dr. med. Ulrike Walter
City
Nürnberg
ZIP/Postal Code
90402
Country
Germany
Facility Name
Dr. Norbert Staab
City
Schlüchtern
ZIP/Postal Code
36381
Country
Germany
Facility Name
Dr. Hannelore Neumaier
City
Wiesbaden
ZIP/Postal Code
65183
Country
Germany
Facility Name
Unidad Médica de Especialidades del Noroeste (UMEN)
City
Centro Culiacán Sinaloa
ZIP/Postal Code
80000
Country
Mexico
Facility Name
Hospital General de Chihuahua. "Dr. Salvador Anchondo"
City
Chihuahua C.P. 31000
Country
Mexico
Facility Name
Hospital Christus Muguerza del Parque
City
Chihuahua CP 3100
Country
Mexico
Facility Name
Internal Medicine Clin Trials (IMED)
City
Col Obispado, Monterrey , N.L. C.P. 64060
Country
Mexico
Facility Name
Hospital Civil de Guadalajara
City
Col. El Retiro CP 44280 Cuadalajara Jalis
Country
Mexico
Facility Name
Grupo Médico Terranova
City
CP 44630 Guadalajara Jalisco
Country
Mexico
Facility Name
Clinical Research Instutute S.C.
City
Edo. de México CP 54055
Country
Mexico
Facility Name
Instituto Biomédico de Investigación A.C.
City
Fracc. Bosques del Prado Norte Aguascalientes
ZIP/Postal Code
CP 20127
Country
Mexico
Facility Name
Unidad de Investigación Clínica Cardiometábolica de Occidente S.C. (UNICAMO)
City
Jalisco, 44150
Country
Mexico
Facility Name
Monterrey International Research Center (MIRC)
City
Nuevo León CP 64000
Country
Mexico
Facility Name
Hospital Universitario Dr. José Eleuterio González. Edificio Elizondo Barragán, Servicio de Otorrinolaringología
City
Nuevo León CP 64400
Country
Mexico
Facility Name
Hospital Central "Dr. Ignacio Morones Prieto" Servicio de Otorrinolaringología
City
San Luis Potosí, SLP, México, 78240
Country
Mexico
Facility Name
Andromed Zoetermeer
City
Zoetermeer
State/Province
EK
ZIP/Postal Code
2724
Country
Netherlands
Facility Name
Andromed Oost
City
Velp
State/Province
ES
ZIP/Postal Code
6883
Country
Netherlands
Facility Name
Rijnland Ziekenhuis, ENT department
City
Leiderdorp
State/Province
GA
ZIP/Postal Code
2353
Country
Netherlands
Facility Name
Andromed Rotterdam
City
Rotterdam
State/Province
HC
ZIP/Postal Code
3021
Country
Netherlands
Facility Name
Adromed Nijmegen
City
Nijmegen
State/Province
HL
ZIP/Postal Code
6533
Country
Netherlands
Facility Name
Andromed Leiden
City
Leiderdorp
State/Province
RA
ZIP/Postal Code
2352
Country
Netherlands
Facility Name
Andromed Breda
City
Breda
State/Province
VL
ZIP/Postal Code
4811
Country
Netherlands
Facility Name
Uniwersytecki Szpital Kliniczny w Bialymstoku
City
Bialystok
ZIP/Postal Code
15-276
Country
Poland
Facility Name
Niepubliczny Zaklad Opieki Zdrowotnej Prywatne Centrum Medyczne PROMEDIS
City
Gdansk
ZIP/Postal Code
80-288
Country
Poland
Facility Name
Szpital Miejski im. J.Brudzinskiego
City
Gdynia
ZIP/Postal Code
81-348
Country
Poland
Facility Name
Samodzielny Publiczny Szpital Kliniczny im. Andrzeja Mieleckiego Slaskiego Uniwersytetu Medycznego w Katowicach
City
Katowice
ZIP/Postal Code
40-027
Country
Poland
Facility Name
NZOZ Specjalistyczne Centrum Medyczne Nowomed
City
Krakow
ZIP/Postal Code
30-349
Country
Poland
Facility Name
Niepubliczny Zaklad Opieki Zdrowotnej PROMED
City
Krakow
ZIP/Postal Code
31- 636
Country
Poland
Facility Name
Specjalistyczny Gabinet Otolaryngologiczny
City
Krakow
ZIP/Postal Code
31-534
Country
Poland
Facility Name
Szpital Specjalistyczny im. Stefana Zeromskiego, SP ZOZ w Krakowie, Oddzial Otolaryngologii
City
Krakow
ZIP/Postal Code
31-913
Country
Poland
Facility Name
Samodzielny Publiczny Zaklad Opieki Zdrowotnej, Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Lodzi
City
Lodz
ZIP/Postal Code
91-153
Country
Poland
Facility Name
Wojewodzki Szpital Specjalistyczny im. Stefana Kardynała Wyszynskiego Samodzielny Publiczny Zaklad Opieki Zdrowotnej
City
Lublin
ZIP/Postal Code
20-718
Country
Poland
Facility Name
Wojewodzki Szpital Specjalistyczny w Olsztynie
City
Olsztyn
ZIP/Postal Code
10-561
Country
Poland
Facility Name
Instytut Fizjologii i Patologii Sluchu
City
Warszawa
ZIP/Postal Code
01-943
Country
Poland
Facility Name
Samodzielny Publiczny Szpital Kliniczny nr 1 we Wroclawiu
City
Wroclaw
ZIP/Postal Code
50-369
Country
Poland
Facility Name
Hospital Militar Regional nº 1 Serviço de Otorrinolaringologia
City
Porto
ZIP/Postal Code
4050-113
Country
Portugal
Facility Name
Louis Leipoldt Mediclinic
City
Bellville
ZIP/Postal Code
7530
Country
South Africa
Facility Name
Lakeview Hospital
City
Benoni
ZIP/Postal Code
1501
Country
South Africa
Facility Name
1007 Louis Pasteur Building
City
Pretoria
ZIP/Postal Code
0002
Country
South Africa
Facility Name
GCT Eastmed Clinical Trial centre
City
Pretoria
ZIP/Postal Code
0186
Country
South Africa
Facility Name
Constantiaberg Medi Clinic,
City
Western Cape
ZIP/Postal Code
7800
Country
South Africa
Facility Name
Prince Alfred House
City
Wynberg
ZIP/Postal Code
7800
Country
South Africa
Facility Name
Hospital Sagunto
City
Sagunto
State/Province
Valencia
ZIP/Postal Code
46520
Country
Spain
Facility Name
Fundación Hospital de Alcorcón, Otorhinolaryngology
City
Alcorcon - Madrid
ZIP/Postal Code
28922
Country
Spain
Facility Name
Hospital Clínico Barcelona, Dept. Of ORL
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital Puerta del Hierro, Madrid- Servicio de ORL
City
Madrid
ZIP/Postal Code
28035
Country
Spain
Facility Name
Hospital Universitario Príncipe de Asturias
City
Madrid
ZIP/Postal Code
28805
Country
Spain
Facility Name
Clínica Universitaria de Navarra, Dept. ORL
City
Pamplona, Navarra
ZIP/Postal Code
31008
Country
Spain
Facility Name
Hospital Universitario de Salamanca- Hospital Virgen de la Vega
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Facility Name
Oldfield Surgery
City
Bath
ZIP/Postal Code
BA2 3HT
Country
United Kingdom
Facility Name
Addenbrooke's Hospital
City
Cambridge
ZIP/Postal Code
CB2 2QQ
Country
United Kingdom
Facility Name
Avondale Surgery, Research Office
City
Chesterfield
ZIP/Postal Code
S40 4TF
Country
United Kingdom
Facility Name
Burbage Surgery
City
Leicestershire
ZIP/Postal Code
LE10 2SE
Country
United Kingdom
Facility Name
The university Hospitals of Leicester, Leicester Royal Infirmary
City
Leicester
ZIP/Postal Code
LE1 5WW
Country
United Kingdom
Facility Name
The Freeman Hospital
City
Newcastle upon Tyne
ZIP/Postal Code
NE7 7DN
Country
United Kingdom
Facility Name
Wansford and Kings Cliffe Practice
City
Petereborough
ZIP/Postal Code
PE8 6PL
Country
United Kingdom
Facility Name
Frome Medical Practice
City
Somerset
ZIP/Postal Code
BA11 1EZ
Country
United Kingdom
Facility Name
Sherbourne Medical Centre
City
Warwickshire
ZIP/Postal Code
CV32 4RA
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

Open-Label, Long-Term Treatment Study, to Assess the Long-Term Safety and Tolerability and Efficacy of Neramexane in Patients With Subjective Tinnitus

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